Ortho-Clinical Diagnostics recalls VITROS 5,1 FS Chemistry System (v3.0 and below) due to software anomaly that may incorrectly extend reagent stability. Affected units have specific product codes and serial numbers.
Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
Ortho-Clinical Diagnostics is recalling VIT: 5,1 FS Chemistry System versions 3.0 and older because a software issue might make the reagent stability time appear longer than it actually is. This could lead to inaccurate test results if the reagent is used after its true expiration.
The software anomaly causes the system to incorrectly show a longer on-analyzer stability time for reagents. This means reagents might be used after they've actually expired, leading to inaccurate test results.
Healthcare facilities using the VITROS 5,1 FS Chemistry System version 3.0 or older are likely affected. Laboratory staff and patients using these systems for clinical testing are at risk of inaccurate results.
Check for product code 6801375, UDI 10758750001132, or serial numbers starting with J34000132 to J34002322. The system is version 3.0 or older for in vitro clinical testing.
Verify the software version of your VITROS 5,1 FS Chemistry System to confirm it is version 3.0 or older.
Ensure reagents are used within their actual stability period, not the extended time shown by the system.
The software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS reagent.
Check for product code 6801375, UDI 10758750001132, or serial numbers starting with J34000132 to J34002322. The system must be version 3.0 or older.
No, but you should verify the software version and ensure reagents are used within their actual stability period.
We’ve drafted a message you can send Ortho-Clinical Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-0651-2019 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-0651-2019 from Ortho-Clinical Diagnostics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
